Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)

NCT ID: NCT01228890

Last Updated: 2012-12-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-04-30

Brief Summary

In this 5-year, two-site randomized clinical trial, we propose to test the efficacy of the CATCH-IT primary care/Internet based depression prevention intervention against Attention Monitoring Psychoeducation (AMPE) in preventing the onset of depressive episodes in an intermediate to high risk group of adolescents aged 13-17. We plan to (a) identify high risk adolescents based on elevated scores on the PHQ-A, a screening measure of depressive symptoms; (b) recruit 400 (200 per site) of these at-risk adolescents to be randomized into either the CATCH-IT or the AMPE group; (c) assess outcomes at 2, 8, 12, 18, and 24 months post intake on measures of depressive symptoms, depressive diagnoses, other mental disorders, and on measures of role impairment in education, quality of life, attainment of educational milestones, and family functioning; and (d) conduct exploratory analyses to examine the effectiveness of this intervention program, moderators of protection, and potential ethnic and cultural differences in intervention response.

Conditions

Depression; Anxiety; Externalizing Symptoms; Substance Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CATCH-IT 2-R Arm

Primary care/Internet based depression prevention intervention (CATCH-IT 2-R) with a family component.

Group Type: EXPERIMENTAL

CATCH-IT

Intervention Type: BEHAVIORAL

The CATCH-IT 2-R intervention has a motivational (3 PCP motivational interviews at time 0, 1.5 months and 12 months and 3 coaching phone calls at 2 and 4 weeks and 18 months) and an Internet component (with separate adolescent \[14 modules\] and parent \[5 modules\] programs). This revised and expanded intervention will include a comprehensive approach to reducing modifiable risk factors and enhancing resiliency factors associated with increased or decreased risk of depression, respectively, proposed by Spence and Reinecke.148 The revised CATCH-IT "Tracker" will monitor time in study and deploy elements of the intervention based on time since enrollment, including computer and human elements (e.g. calls, doctor visits).

Attention Monitoring Psycho-education (AMPE) Arm

Group Type: ACTIVE_COMPARATOR

AMPE

Intervention Type: BEHAVIORAL

The AMPE components are similar to those employed in previous primary care based quality improvement/Chronic Care Model Interventions (patient education \[psycho-education described below\], provider training \[described in Case Finding and Recruitment\], active monitoring and referral \[case management, discussed under assessments\], physician and nurse education and routine contact with PCP \[study design rationale\]). This Internet site will focus on assisting parents and adolescents in early identification of need for treatment and will also target stigma and negative attitudes toward treatment of mental disorders we have previously identified as barriers to seeking and adhering to treatment.

Interventions

CATCH-IT

The CATCH-IT 2-R intervention has a motivational (3 PCP motivational interviews at time 0, 1.5 months and 12 months and 3 coaching phone calls at 2 and 4 weeks and 18 months) and an Internet component (with separate adolescent \[14 modules\] and parent \[5 modules\] programs). This revised and expanded intervention will include a comprehensive approach to reducing modifiable risk factors and enhancing resiliency factors associated with increased or decreased risk of depression, respectively, proposed by Spence and Reinecke.148 The revised CATCH-IT "Tracker" will monitor time in study and deploy elements of the intervention based on time since enrollment, including computer and human elements (e.g. calls, doctor visits).

Intervention Type: BEHAVIORAL

AMPE

The AMPE components are similar to those employed in previous primary care based quality improvement/Chronic Care Model Interventions (patient education \[psycho-education described below\], provider training \[described in Case Finding and Recruitment\], active monitoring and referral \[case management, discussed under assessments\], physician and nurse education and routine contact with PCP \[study design rationale\]). This Internet site will focus on assisting parents and adolescents in early identification of need for treatment and will also target stigma and negative attitudes toward treatment of mental disorders we have previously identified as barriers to seeking and adhering to treatment.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Youth ages 13 through 17.
• Youth must be experiencing elevated level of depressive symptoms on the Center for Epidemiologic Studies Depression46 (CES-D) scale (score >/= 16) and have at least two core symptoms of Major Depression on the Patient Health Questionnaire, Adolescents.
• Youth will be included if they have a past history of depression, anxiety, externalizing symptoms, or substance abuse.

Exclusion Criteria

• Current DSM-IV diagnosis (Kiddie Schedule of Affective Disorders) of Major Depressive Disorder, current therapy for depression, or be taking antidepressants (e.g., SSRIs, TCAs, MAOIs, bupropion, nefazodone, mirtazapine, venlafaxine).
• Current CES-D score >35
• DSM-IV diagnosis of schizophrenia (current or past) or bipolar affective disorder
• Current serious medical illness that causes significant disability or dysfunction
• Significant reading impairment (a minimum sixth-grade reading level based on parental report), mental retardation, or developmental disabilities
• Serious imminent suicidal risk (as determined by endorsement of current suicidality on CES-D or in KSADS interview) or other conditions that may require immediate psychiatric hospitalization
• Psychotic features or disorders, or currently be receiving psychotropic medication
• Extreme, current drug/alcohol abuse (greater than or equal to 2 on the CRAFFT).

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harvard Vanguard Medical Associates

OTHER

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Van Voorhees, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago

Chicago, Illinois, United States

Access Community Health Network

Chicago, Illinois, United States

Northshore University Health Systems

Evanston, Illinois, United States

Harvard Vanguard Medical Associates

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

10-464-A

Identifier Type: -

Identifier Source: org_study_id